Glenmark Pharma gets US FDA approval for two generic drugs

21 January 2016

India’s Glenmark Pharma (BSE: 532296) on Thursday said it has received final approval from the US Food and Drug Administration to manufacture and market potassium chloride extended release capsules and oral contraceptive norethindrone acetate and ethinyl estradiol tablets in the US market.

The company said the approved product has an estimated US market size of $74.1 million for the 12 months ended November 2015, citing IMS data.

Glenmark Pharma has also received approval for norethindrone acetate and ethinyl estradiol tablets. It is a generic version of US-based Warner Chilcott's oral contraceptive drug Leostrin21.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK